TA
Quality Engineer
- Hiring from
- Germany
- Work type
- Hybrid
- Posted
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About The Company
Ypsomed is a successful, family-owned medical technology company with more than 2,000 employees worldwide. Headquartered in Burgdorf, Switzerland, the Group develops and manufactures injection and infusion systems that support self-medication. Its products help people living with chronic conditions, including diabetes, obesity and certain types of cancer, manage their treatment with greater independence and freedom.
Ypsomed Produktion GmbH operates a modern manufacturing facility in Schwerin, Germany. The site began production in 2019 and continues to expand in support of the company’s global growth. Employees work in a contemporary production and office environment, contributing to medical technology solutions used around the world.
About The Role
Ypsomed is seeking a Quality Engineer (m/w/d) to help bring advanced medical technology products to market. Based in Schwerin, this is a full-time position of 40 hours per week, with hybrid working arrangements. The reference number for this vacancy is 8205.
In this role, you will help ensure that manufacturing processes and products meet applicable quality requirements, standards and regulations. You will work closely with production and other teams to establish effective quality controls, investigate issues, support process improvements and maintain appropriate documentation. Your structured approach and attention to detail will help protect product quality throughout manufacturing and support the reliable supply of medical devices.
Qualifications
You have completed a degree in an engineering, technical or scientific discipline, or hold a comparable qualification. Relevant experience in the manufacture or testing of sterile or non-sterile medical devices is desirable. Candidates who meet the role’s foundational requirements and are prepared to develop further expertise in this area are also encouraged to apply.
You bring knowledge of quality management or regulatory affairs, including standards and regulations such as ISO 13485, ISO 14971, MDSAP and the EU Medical Device Regulation (EU) 2017/745. Familiarity with quality tools such as 8D problem solving and CAPA is beneficial. Experience with Microsoft Office, SAP—particularly S/4HANA—and TrackWise is welcome.
Experience in injection moulding, automated assembly or the manufacture of individual components through metalworking would be an advantage. You communicate very well in German and have good written and spoken English skills. A careful, organized and collaborative working style will help you succeed in this position.
Responsibilities
Plan, establish and monitor quality assurance measures for the manufacture of medical devices. Help ensure that production activities comply with relevant quality requirements, standards and legislation. Support product release and address manufacturing quality matters through root-cause analysis, change management and complaint management.
Coordinate the investigation and resolution of nonconformities, including the implementation and follow-up of corrective and preventive actions (CAPAs). Review and approve qualification and validation documentation for industrialization projects, as well as manufacturing documentation. Provide support for qualification and process validation activities, and contribute to internal audits, customer audits and regulatory authority inspections.
Benefits
Ypsomed offers a modern workplace and a range of practical employee benefits. These include an employer contribution of €40 per month toward the company pension scheme, annual vacation and Christmas payments, and mobility support through electric vehicle charging stations, parking, public transport connections and fuel vouchers.
Additional benefits include corporate discounts, a JobRad bicycle program, employee events, Epassi offerings and Babbel language courses. Hybrid working provides flexibility, while modern production facilities and office spaces support an effective working environment.
Equal Opportunity
Ypsomed Produktion GmbH is committed to fair and respectful recruitment. We welcome applications from qualified candidates and assess applicants based on their skills, experience and suitability for the role, without discrimination. Please include your salary expectations and earliest possible start date with your application.
Ypsomed is a successful, family-owned medical technology company with more than 2,000 employees worldwide. Headquartered in Burgdorf, Switzerland, the Group develops and manufactures injection and infusion systems that support self-medication. Its products help people living with chronic conditions, including diabetes, obesity and certain types of cancer, manage their treatment with greater independence and freedom.
Ypsomed Produktion GmbH operates a modern manufacturing facility in Schwerin, Germany. The site began production in 2019 and continues to expand in support of the company’s global growth. Employees work in a contemporary production and office environment, contributing to medical technology solutions used around the world.
About The Role
Ypsomed is seeking a Quality Engineer (m/w/d) to help bring advanced medical technology products to market. Based in Schwerin, this is a full-time position of 40 hours per week, with hybrid working arrangements. The reference number for this vacancy is 8205.
In this role, you will help ensure that manufacturing processes and products meet applicable quality requirements, standards and regulations. You will work closely with production and other teams to establish effective quality controls, investigate issues, support process improvements and maintain appropriate documentation. Your structured approach and attention to detail will help protect product quality throughout manufacturing and support the reliable supply of medical devices.
Qualifications
You have completed a degree in an engineering, technical or scientific discipline, or hold a comparable qualification. Relevant experience in the manufacture or testing of sterile or non-sterile medical devices is desirable. Candidates who meet the role’s foundational requirements and are prepared to develop further expertise in this area are also encouraged to apply.
You bring knowledge of quality management or regulatory affairs, including standards and regulations such as ISO 13485, ISO 14971, MDSAP and the EU Medical Device Regulation (EU) 2017/745. Familiarity with quality tools such as 8D problem solving and CAPA is beneficial. Experience with Microsoft Office, SAP—particularly S/4HANA—and TrackWise is welcome.
Experience in injection moulding, automated assembly or the manufacture of individual components through metalworking would be an advantage. You communicate very well in German and have good written and spoken English skills. A careful, organized and collaborative working style will help you succeed in this position.
Responsibilities
Plan, establish and monitor quality assurance measures for the manufacture of medical devices. Help ensure that production activities comply with relevant quality requirements, standards and legislation. Support product release and address manufacturing quality matters through root-cause analysis, change management and complaint management.
Coordinate the investigation and resolution of nonconformities, including the implementation and follow-up of corrective and preventive actions (CAPAs). Review and approve qualification and validation documentation for industrialization projects, as well as manufacturing documentation. Provide support for qualification and process validation activities, and contribute to internal audits, customer audits and regulatory authority inspections.
Benefits
Ypsomed offers a modern workplace and a range of practical employee benefits. These include an employer contribution of €40 per month toward the company pension scheme, annual vacation and Christmas payments, and mobility support through electric vehicle charging stations, parking, public transport connections and fuel vouchers.
Additional benefits include corporate discounts, a JobRad bicycle program, employee events, Epassi offerings and Babbel language courses. Hybrid working provides flexibility, while modern production facilities and office spaces support an effective working environment.
Equal Opportunity
Ypsomed Produktion GmbH is committed to fair and respectful recruitment. We welcome applications from qualified candidates and assess applicants based on their skills, experience and suitability for the role, without discrimination. Please include your salary expectations and earliest possible start date with your application.
